Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in Brazil
The objective of this study was to analyze the level of evidence regarding the efficacy, effectiveness and safety of over-the-counter (OTC) cough medications registered in Brazil. The National Health Surveillance Agency database was used to identify the drugs. Clinical trials, systematic reviews, me...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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Universidade de São Paulo
2010-03-01
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| Series: | Brazilian Journal of Pharmaceutical Sciences |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000100016 |
| _version_ | 1811272084567883776 |
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| author | Adriano Max Moreira Reis Albert Figueras |
| author_facet | Adriano Max Moreira Reis Albert Figueras |
| author_sort | Adriano Max Moreira Reis |
| collection | DOAJ |
| description | The objective of this study was to analyze the level of evidence regarding the efficacy, effectiveness and safety of over-the-counter (OTC) cough medications registered in Brazil. The National Health Surveillance Agency database was used to identify the drugs. Clinical trials, systematic reviews, meta-analyses, and studies on safety were searched on the Medline baseline, the Cochrane Library and SIETES (System of Essential Information in Therapeutics and Health; database in Spanish). Most drugs (62.5%) were sold as a fixed-dose combination of two or more drugs. Randomized clinical trials were found for only three drugs: bromhexine, dextromethorphan and guaifenesin. No clinical trials were found for fixed-dose combinations. Systematic reviews on Cochrane did not report any evidence in favor of or against the effectiveness of cough drugs. Efficacy is also unclear, especially regarding fixed-dose combinations. The evidence for the efficacy of OTC cough medications available in Brazil is poor due to the lack of quality studies. Pharmacovigilance of OTC cough medications should be encouraged.<br>O objetivo deste trabalho foi analisar o nível de evidências sobre a eficácia, a efetividade e a segurança dos medicamentos para tosse registrados no Brasil. A base de dados da Agência Nacional de Vigilância Sanitária foi empregada para identificar os medicamentos. Os ensaios clínicos, as revisões sistemáticas, as metanálises e os estudos de segurança foram pesquisados no Medline, the Cochrane Library e SIETES (Sistema de Informações Essenciais em Terapêutica e Saúde, base de dados em espanhol). A maioria dos medicamentos (62,5%) eram comercializados como associação em dose fixa com dois ou mais fármacos. Ensaios clínicos randomizados foram encontrados apenas para três fármacos: bromexina, dextrometorfano e guaifenesina; para associações a dose fixa não foram encontrados ensaios clínicos. Revisões sistemáticas publicadas pela Cochrane não encontraram evidências favoráveis ou contrárias à efetividade dos medicamentos para tosse. Essa eficácia não é clara, especialmente a das associações a dose fixa. As evidências sobre a eficácia dos medicamentos para tosse isentos de prescrição disponíveis no mercado brasileiro são fracas, devido à falta de pesquisas de boa qualidade. A farmacovigilância de medicamentos para tosse isentos de prescrição deve ser incentivada. |
| first_indexed | 2024-04-12T22:34:02Z |
| format | Article |
| id | doaj.art-7ca434e080e647038b91af27d6be2bc8 |
| institution | Directory Open Access Journal |
| issn | 1984-8250 2175-9790 |
| language | English |
| last_indexed | 2024-04-12T22:34:02Z |
| publishDate | 2010-03-01 |
| publisher | Universidade de São Paulo |
| record_format | Article |
| series | Brazilian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-7ca434e080e647038b91af27d6be2bc82022-12-22T03:13:54ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences1984-82502175-97902010-03-0146113514510.1590/S1984-82502010000100016Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in BrazilAdriano Max Moreira ReisAlbert FiguerasThe objective of this study was to analyze the level of evidence regarding the efficacy, effectiveness and safety of over-the-counter (OTC) cough medications registered in Brazil. The National Health Surveillance Agency database was used to identify the drugs. Clinical trials, systematic reviews, meta-analyses, and studies on safety were searched on the Medline baseline, the Cochrane Library and SIETES (System of Essential Information in Therapeutics and Health; database in Spanish). Most drugs (62.5%) were sold as a fixed-dose combination of two or more drugs. Randomized clinical trials were found for only three drugs: bromhexine, dextromethorphan and guaifenesin. No clinical trials were found for fixed-dose combinations. Systematic reviews on Cochrane did not report any evidence in favor of or against the effectiveness of cough drugs. Efficacy is also unclear, especially regarding fixed-dose combinations. The evidence for the efficacy of OTC cough medications available in Brazil is poor due to the lack of quality studies. Pharmacovigilance of OTC cough medications should be encouraged.<br>O objetivo deste trabalho foi analisar o nível de evidências sobre a eficácia, a efetividade e a segurança dos medicamentos para tosse registrados no Brasil. A base de dados da Agência Nacional de Vigilância Sanitária foi empregada para identificar os medicamentos. Os ensaios clínicos, as revisões sistemáticas, as metanálises e os estudos de segurança foram pesquisados no Medline, the Cochrane Library e SIETES (Sistema de Informações Essenciais em Terapêutica e Saúde, base de dados em espanhol). A maioria dos medicamentos (62,5%) eram comercializados como associação em dose fixa com dois ou mais fármacos. Ensaios clínicos randomizados foram encontrados apenas para três fármacos: bromexina, dextrometorfano e guaifenesina; para associações a dose fixa não foram encontrados ensaios clínicos. Revisões sistemáticas publicadas pela Cochrane não encontraram evidências favoráveis ou contrárias à efetividade dos medicamentos para tosse. Essa eficácia não é clara, especialmente a das associações a dose fixa. As evidências sobre a eficácia dos medicamentos para tosse isentos de prescrição disponíveis no mercado brasileiro são fracas, devido à falta de pesquisas de boa qualidade. A farmacovigilância de medicamentos para tosse isentos de prescrição deve ser incentivada.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000100016MedicamentosTosseMedicamentosFarmacovigilânciaFarmacoepidemiologiaDrugsCoughDrugsPharmacovigilancePharmacoepidemiology |
| spellingShingle | Adriano Max Moreira Reis Albert Figueras Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in Brazil Brazilian Journal of Pharmaceutical Sciences Medicamentos Tosse Medicamentos Farmacovigilância Farmacoepidemiologia Drugs Cough Drugs Pharmacovigilance Pharmacoepidemiology |
| title | Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in Brazil |
| title_full | Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in Brazil |
| title_fullStr | Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in Brazil |
| title_full_unstemmed | Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in Brazil |
| title_short | Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in Brazil |
| title_sort | analysis of the evidence of efficacy and safety of over the counter cough medications registered in brazil |
| topic | Medicamentos Tosse Medicamentos Farmacovigilância Farmacoepidemiologia Drugs Cough Drugs Pharmacovigilance Pharmacoepidemiology |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000100016 |
| work_keys_str_mv | AT adrianomaxmoreirareis analysisoftheevidenceofefficacyandsafetyofoverthecountercoughmedicationsregisteredinbrazil AT albertfigueras analysisoftheevidenceofefficacyandsafetyofoverthecountercoughmedicationsregisteredinbrazil |